MEKTOVI (binimetinib)

MEKTOVI (binimetinib)

SELF ADMINISTRATION - ORAL

Indications for Prior Authorization:

• BRAF V600E or V600K unresectable or metastatic melanoma: Indicated in combination with Braftovi™ (encorafenib capsules), for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA approved test.
• Non-Small Cell Lung Cancer (NSCLC): Indicated in combination with Braftovi (encorafenib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.

Coverage Criteria:

For diagnosis of melanoma:

• Patient has unresectable, advanced, or metastatic melanoma, AND
• Cancer is BRAF V600E or V600K mutant type as detected by an FDA-approved test (THxID-BRAF Kit) or performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) AND
• Mektovi will be used in combination with Braftovi™ (encorafenib capsules) AND
• One of the following: 
  • Trial and failure, contraindication or intolerance to one of the following: 
    • Cotellic
    • Mekinist; OR
  • For continuation of prior therapy

For diagnosis of Non-Small Cell Lung Cancer (NSCLC):

• Diagnosis of metastatic non-small cell cancer AND
• Cancer is BRAF V600E mutant type as detected by an FDA-approved test (THxID-BRAF Kit) or performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) AND
• Used in combination with encorafenib

Reauthorization Criteria:

For diagnosis of all indications listed above:

• Patient does not show evidence of progressive disease while on therapy

Dosing:

• 45 mg orally taken twice daily in combination with encorafenib until disease progression or unacceptable toxicity.

Coverage Duration:

Initial: 1 year

Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Policy Updates:

• 08/27/2019 - Initial review
• 4/1/24 –Updated criteria to include NSCLC indication, Updated Melanoma indication to include trial and failure of Cotellic and Mekinist, Reauthorization Criteria added in

References:

1. Mektovi Prescribing Information. Array Biopharma Inc. Boulder, CO. October 2023. 
2. National Comprehensive Cancer Network (NCCN). Clinical practice guidelines in oncology: Melanoma: Cutaneous v.3.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/cutaneous_melanoma.pdf. Accessed May 23, 2022.